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NCT07729150From ClinicalTrials.govRecruiting

Reduce HEAT: A Randomized Trial of Wearable Thermal Devices for ADT-Induced Hot Flashes

Reduce Hot flashEs AssociaTed With ADT (Reduce HEAT) - a Prospective Randomized Clinical Trial of a Wearable Thermal Device for Patients With Prostate Cancer on ADT With Bothersome Vasomotor Symptoms

  • Prostate Cancer
  • Hot Flashes
  • Vasomotor Symptoms

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Dana-Farber Cancer Institute
Enrolment target
66
Started
1 October 2026
Main results due
31 December 2027
Study sites
1
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Men only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Patients with a clinical or pathologic confirmed diagnosis of prostate cancer
* Patients must be undergoing treatment with standard androgen deprivation therapy (i.e., GnRH agonist or antagonist) for ≥ 4 weeks. Patients must remain on ADT for the duration of the study (12 weeks); they may receive treatment with an androgen receptor pathway inhibitor (ARPI), radioligand therapy, or immunotherapy combined with ADT.
* Patients must report bothersome hot flash symptoms (defined as ≥ 28 hot flashes per week, perceived to be at least moderately bothersome to the patient), during a period of at least 30 days prior to entering the study.
* Age ≥18 years.
* ECOG performance status ≤ 2
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Pregnant and nursing women are excluded as prostate cancer is a disease of men.
* Participants with a concurrent diagnosis, including separate malignancy, that may limit life expectancy \< 6 months.
* Systemic antineoplastic therapy besides approved ARPI, radioligand therapy, and immunotherapy - enrollment in a clinical trial that is using SOC therapeutic options in these categories is allowed.

What this study is about

In the sponsor’s own words, from the registry.

This is a prospective, randomized, non-pharmacologic interventional trial evaluating the effectiveness of the Embr Wave wearable thermal device in reducing hot flash burden in men with prostate cancer receiving androgen deprivation therapy (ADT). Participants will be randomized 1:1 to immediate (12 weeks) versus delayed (after 6 weeks) use of the Embr Wave device. The study aims to determine whether the device reduces vasomotor symptoms using a number of patient-reported outcomes

Study sites(1)

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07729150. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Reduce HEAT: A Randomized Trial of Wearable Thermal Devices for ADT-Induced Hot Flashes | Trialion